Integration of Physiologically Based Pharmacokinetic (PBPK) Modeling with IVIVC for Precision Dosing
Keywords:
Physiologically Based Pharmacokinetic (PBPK) Modeling, In Vitro–In Vivo Correlation (IVIVC), Precision Dosing, Model-Informed Drug Development (MIDD), Pharmacokinetics, Drug Absorption, Personalized Medicine,Biopharmaceutics, Regulatory Science, Simulation and ModelingAbstract
Precision dosing aims to optimize therapeutic outcomes by tailoring drug administration to individual patient characteristics. Physiologically Based Pharmacokinetic (PBPK) modeling has emerged as a powerful tool for predicting drug absorption, distribution, metabolism, and excretion based on physiological and biochemical parameters. In parallel, In Vitro–In Vivo Correlation (IVIVC) facilitates the translation of in vitro drug dissolution data to in vivo performance, traditionally aiding in formulation development and regulatory decisions. Integrating PBPK modeling with IVIVC represents a promising strategy to enhance predictive accuracy in pharmacokinetics and support model-informed precision dosing. This article explores the scientific rationale, methodologies, and practical applications of this integrated approach. We discuss how the synergy between PBPK and IVIVC can improve drug development efficiency, reduce the need for extensive clinical trials, and enable personalized therapeutic regimens. Additionally, we highlight current challenges, such as data requirements and regulatory acceptance, and provide a forward-looking perspective on advancements in computational pharmacology that may further empower this integration.
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